| Chronic obstructive pulmonary disease(COPD)is a progressive inflammatory disease characterized by persistent airflow limitation.COPD is not curable and its prevalence continues to increase worldwide,although it is a preventable and treatable disease.It has a considerable economic and social impact,and remains a major cause of morbidity and mortality.The aims of effective COPD management are to improve symptoms,inrease exercise endurance and health status,prevent and deal with exacerbations,prevent disease progression,and decrease mortality.Up to date,no COPD treatment has been shown to mitigate the deterioration of pulmonary function that occurs,and patients commonly require the progressive introduction of additional treatments.Bronchodilators play a vital role in the pharmacological management of COPD,and are administered regularly or on an as-needed basis to relieve or prevent symptoms.Guidelines recommend the regular use of long-acting bronchodilators,which are more effective and convenient than their short-acting counterparts.Combination therapy with two long-acting bronchodilators is recommended for patients whose disease is not adequately controlled with monotherapy.The GOLD report advocates a combination of two long-acting bronchodilators as an alternative first-line treatment for patients in groups B(i.e.those with a low risk of exacerbation but more significant symptoms),C(high risk/less symptoms)or D(high risk/more symptoms).Combining bronchodilators from separate pharmacological classes may offer improved efficacy and a lower incidence of adverse events compared with increasing the dose of a single bronchodilator.For instance,combining a LAMA with a LABA results in greater improvements in FEV1 than monotherapy with either drug alone and is not associated with any untoward safety issues.Umeclidinium/vilanterol,approved in December of 2013 by the FDA,is a dry powder for inhalation bronchodilator that is used for the treatment of COPD,including chronic bronchitis and emphysema.It is approved for oral inhalation in adults with COPD in several countries,including the USA,Canada and those of the EU.Differences among umeclidinium/vilanterol,placebo,umeclidinium,vialnterol and fluticasone propionate/salmeterol exist with respect to the clinical efficacy,possible side-effect profiles,as well as market prices.We conducted this review to assess the relative effect and safety of umeclidinium/vilanterol versus placebo,umeclidinium,vilanterol or fluticasone propionate/salmeterol in patients with COPD.The study is divided into four parts:PART ⅠEffect and safety of umeclidinium plus vilanterol versus placebo for patients with chronic obstructive pulmonary diseaseObjectiveTo assess the effect and safety of umeclidinium plus vilanterol versus placebo in adult patients with chronic obstructive pulmonary disease.MethodsWe electronically searched MEDLINE,EMBASE,CENTRAL and CBM for randomized controlled trials about umeclidinium plus vilanterol versus placebo in adult patients with chronic obstructive pulmonary disease.Study quality was assessed using the criteria outlined in the Cochrane Handbook for Systematic Reviews of intervention.Meta-analysis was conducted by RevMan 5.3.Results1.Trough FEV1 was higher in umeclidinium/vilanterol group in comparison to placebo(MD:0.20,95%CI 0.18-0.23,P<0.00001).2.Compared with placebo,umeclidinium plus vilanterol significantly increased FVC(MD:030,95%CI 0.24-0.36,P<0.00001).3.The improvements of TDI scores were higher in umeclidinium/vilanterol group compared with placebo(MD:0.97,95%CI 0.70-1.23,P<0.00001)4.Umeclidinium plus vilanterol significantly decreased SOBDA,when compared with placebo(MD:-0.16,95%Cl-0.23--0.09,P<0.00001).5.There was significant decrease on SGRQ scores in umeclidinium/vilanterol in comparison to placebo group(MD:-3.90,95%Cl-4.99--2.81,P<0.00001).6.Compared with placebo,umeclidinium plus vilanterol significantly decreased usage of rescue medicine(MD:-0.86,95%Cl-1.09--0.63,P<0.00001).7.The incidence of nasopharyngitis(OR:0.97,95%CI 0.76-1.24,P=(0.81)、nasosinusitis(OR:0.62,95%CI 0.25-1.57,P=0.31).cough(OR:1.09,95%CI 0.67-1.76,P=0.73)、upper respiratory tract infection(OR:0.84,95%CI 0.48-1.48,P=0.54).toothache(OR:1.00,95%CI0.49-1.04,P=1.00)、headache(OR:0.81,95%CI 0.01-1.07,P=0.14).back pain(OR:0.63,95%CI 0.37-1.08,P=0.09)、arthralgia(OR:1.41,95%CI 0.70-2.86,P=0.34).cardiovascular events(OR:1.04,95%CI 0.43-2.49,P=0.93).antichoinergic syndrome(OR:1.03,95%CI 0.42-2.54,P=0.95)was similar in the two treatment groups.The incidence of dyspnea(OR:0.17,95%CI 0.04-0.72,P=0.02)was lower in umeclidinium plus vilanterol group in comparison to placebo.ConclusionsCompared with placebo,umeclidinium plus vilanterol effectively improved trough FEV1,FVC,TDI,and significantly reduced SOBDA,SGRQ,the usage of rescue medicine.There was no evidence that umeclidinium plus vilanterol could significantly reduce nasopharynitis,nasosinusitis,upper respiratory tract infection,cough,headache,toothache,back pain,arthralgia,anticholinergic syndrome,cardiovascular events in patients with chronic obstructive pulmonary disease.The incidence of dyspnea was lower in umeclidinium plus vilanterol group.PART ⅡEffect and safety of umeclidinium plus vilanterol versus umeclidinium for patients with chronic obstructive pulmonary diseaseObjectiveTo assess the effect and safety of umeclidinium plus vilanterol versus umeclidinium in adult patients with chronic obstructive pulmonary disease.MethodsWe electronically searched MEDLINE,EMBASE,CENTRAL and CBM for randomized controlled trials about umeclidinium plus vilanterol versus umeclidinium in adult patients with chronic obstructive pulmonary disease.Study quality was assessed using the criteria outlined in the Cochrane Handbook for Systematic Reviews of intervention.Meta-analysis was conducted by RevMan 5.3.Results1.Trough FEV,was higher in umeclidinium/vilanterol group in comparison to umeclidinium(MD:0.06,95%CI 0.05-0.08,P<0.00001).2.Compared with umeclidinium,umeclidinium plus vilanterol significantly increased FVC(MD:0.07,95%CI 0.04-0.10,P<0.00001).3.The improvements of TDI scores were higher in umeclidinium/vilanterol group compared with umeclidinium group(MD:0.42,95%CI 0.17-0.68,P=0.0010)4.Umeclidinium plus vilanterol significantly decreased SOBDA,when compared with umeclidinium(MD:-0.09,95%CI-0.13--0.04,P=0.0002).5.There was significant decrease on SGRQ scores in umeclidinium/vilanterol group in comparison to umeclidinium group(MD:-2.09,95%CI-3.22--0.97,P=0.0003).6.Compared with umeclidinium,umeclidinium plus vilanterol significantly decreased usage of rescue medicine(MD:-0.43,95%CI-0.58--0.28,P<0.0001).7.The incidence of nasopharyngitis(OR:1.58,95%CI 0.99-2.53,P=0.06)、nasosinusitis(OR:0.46,95%CI 0.14-0.57,P=0.19).cough(OR:0.75,95%CI 0.35-1.64,P=0.47).headache(OR:1.04,95%CI 0.81-1.33,P=0.74).toothache(OR:0.62,95%CI 0.26-1.46,P=0.28)、back pain(OR:0.83,95%CI 0.63-1.28,P=0.39)、arthralgia(OR:0.79,95%CI 0.21-2.98,P=0.73).anticholinergic syndrome(OR:0.78,95%CI 0.32-1.89,P=0.58)was similar between the two treatment groups.The incidence of cardiovascular events(OR:0.61,95%CI 0.42-0.89,P=0.01)、upper respiratory tract infection(OR:0.63,95%CI 0.42-0.94,P=0.03)、dyspnea(OR:0.14,95%CI 0.03-0.60,P=0.08)was lower in umeclidinium plus vilanterol group in comparison to umeclidinium group.ConclusionsCompared with umeclidinium,umeclidinium plus vilanterol effectively improved trough FEV1,FVC,TDI,and significantly reduced SOBDA,SGRQ,the usage of rescue medicine.There was no evidence that umeclidinium plus vilanterol could significantly reduce nasopharynitis,nasosinusitis,cough,headache,toothache,back pain,arthralgia and anticholinergic syndrome in patients with chronic obstructive pulmonary disease.The incidence of cardiovascular events,upper respiratory tract infection and dyspnea was lower in umeclidinium plus vilanterol group.PART ⅢEffect and safety of umeclidinium plus vilanterol versus vilanterol for patients with chronic obstructive pulmonary diseaseObjectiveTo assess the effects and safety of umeclidinium plus vilanterol versus vilanterol in adult patients with chronic obstructive pulmonary disease.MethodsWe electronically searched MEDLINE,EMBASE,CENTRAL and CBM for randomized controlled trials about umeclidinium plus vilanterol versus vilanterol in adult patients with chronic obstructive pulmonary disease.Study quality was assessed using the criteria outlined in the Cochrane Handbook for Systematic Reviews of intervention.Meta-analysis was conducted by RevMan 5.3.Results1.Trough FEV,was higher in umeclidinium/vilanterol group in comparison to vilanterol(MD:0.09,95%Cl 0.08-0.11,P<0.00001).2.Compared with vilanterol,umeclidinium plus vilanterol significantly increased FVC(MD:0。16,95%CI 0,13-0.20,P<0.00001).3.The improvements of TDI scores were higher in umeclidinium/vilanterol group compared with vianterol group(MD:0.45,95%CI 0.22-0.67,P<0.0001)4.Umeclidinium plus vilanterol significantly decreased SOBDA,when compared with vilanterol(MD:-0.05,95%CI-0.10--0.01,P=0.02).5.There was no difference on SGRQ scores between umeclidinium/vilanterol and vilanterol group(MD:-0.79,95%CI-2.53--0.95,P=0.38)6.Compared with vilanterol,umeclidinium plus vilanterol significantly decreased usage of rescue medicine(MD:-0.21,95%CI-0.36--0.06,P=0.005)7.The incidence of nasopharyngitis(OR:0.97,95%CI 0.76-1.24,P=0.81)、nasosinusitis(OR:0.47,95%CI 0.05-4.32,P=0.50).cough(OR:1.11,95%Cl 0.74-1.66,P=0.61).headache(OR:0.84,95%CI 0.55-1.30,P=0.44).toothache(OR:0.82,95%Cl 0.48-1.39,P=0.46)、back pain(OR:1.32,95%CI 0.66-2.71,P=0.61)、arthralgia(OR:1.84,95%Cl 0.86-3.94,P=0.12)、anticholinergic syndrome(OR:0.74,95%CI 0.16-3.33,P=0.69).cadiovascular events(OR:0.57,95%Cl 0.31-1.05,P=0.07)、upper respiratory tract infection(OR:0.88,95%CI 0.57-1.37,P=0.57)、dyspnea(OR:0.17,95%Cl 0.02-1.48,P=0.11)was similar between the two treatment groups.ConclusionsCompared with vilanterol,umeclidinium plus vilanterol effectively improved trough FEV1,FVC,TDI,and significantly reduced SOBDA,the usage of rescue medicine.There was no expectant difference on SGRQ by comparing umeclidinium group to vilanterol group.There was no evidence that umeclidinium plus vilanterol could significantly reduce nasopharynitis,nasosinusitis,upper respiratory tract infection,cough,headache,toothache,back pain,arthralgia,anticholinergic syndrome,cardiovascular events and dyspnea in patients with chronic obstructive pulmonary disease.PART ⅣEffect and safety of umeclidinium plus vilanterol versus fluticasone propionate plus salmeterol for patients with chronic obstructive pulmonary diseaseObjectiveTo assess the effects and safety of umeclidinium plus vilanterol versus fluticasone propionate plus salmeterol in adult patients with chronic obstructive pulmonary disease.MethodsWe electronically searched MEDLINE,EMBASE,CENTRAL and CBM for randomized controlled trials about umeclidinium plus vilanterol versus fluticasone propionate plus salmeterol in adult patients with chronic obstructive pulmonary disease.Study quality was assessed using the criteria outlined in the Cochrane Handbook for Systematic Reviews of intervention,Meta-analysis was conducted by RevMan 5.3.Results1.Trough FEV1 was higher in umeclidinium/vilanterol group in comparison to fluticasone propionate/salmeterol group(MD:0.09,95%CI 0.07-0.11,P<0.00001).2.Compared with fluticasone propionate/salmeterol,umeclidinium plus vilanterol significantly increased trough FVC(MD:0.17,95%CI 0.13-0.20,P<0.00001).3.The improvements of TDI scores were higher in umeclidinium/vilanterol group compared with fluticasone propionate/salmeterol group(MD:0.33,95%CI 0.09-0.57,P=0.008)4.There were no difference on the improvements of SGRQ scores between umeclidinium/vilanterol and vilanterol group(MD:0.58,95%CI-0.27-1.44,P=0.18)5.The improvements of CAT scores were similar in umeclidinium/vilanterol group compared with fluticasone propionate/salmeterol group(MD:0.31,95%CI-0.26-0.87,P=0.29)6.EQ-5D utility score was similar in umeclidinium/vilanterol group compared with fluticasone propionate/salmeterol group(MD:0.01,95%CI-0.01-0.03,P=0.36)7.Compared with fluticasone propionate/salmeterol,umeclidinium plus vilanterol significantly decreased usage of rescue medicine(MD:-0.13,95%CI-0.26--0.01,P=0.04)8.The incidence of nasopharyngitis(OR:1.62,95%CI 0.98-2.69,P=0.06)、pneumonia(OR:0.37,95%CI 0.11--1.25,P=0.11)、LRTI(excluding pneumonia)(OR:0.83,95%CI 0.25-2.73,P=0.76)、headache(OR:1.25,95%CI 0.89-1.75,P=0.20).cardiac arrhythmias(OR:1.00,95%CI 0.39-2.53,P=l.00).cardiac ischemia(OR:1.18,95%CI 0.38-3.69,P=0.77)、COPD exacerations(OR:1.16,95%Cl 0.68-2.00,P=0.58)was similar between the two treatment groups.ConclusionsCompared with fluticasone propionate/salmeterol,umeclidinium plus vilanterol effectively improved trough FEV1,FVC,TDI;and significantly reduced the usage of rescue medicine.There were no expectant differences on SGRQ scores,CAT scores,EQ-5D utility score by comparing umeclidinium group to fluticasone propionate/salmeterol group.There was no evidence that umeclidinium plus vilanterol could significantly reduce nasopharynitis,nasosinusitis,upper respiratory tract infection,cough,headache,toothache,back pain,arthralgia,anticholinergic syndrome,cardiovascular events and dyspnea in patients with chronic obstructive pulmonary disease. |
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